Vascular hole closure device

ABSTRACT

A device for closing an aperture in a vessel wall comprising a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture and having a first opening. A first retainer is positionable external of the vessel. A flexible connecting member operatively connects the covering member and the first retainer, wherein the first opening of the covering member is configured to restrict movement of the connecting member.

This application claims priority from provisional application No.61/241,555, filed Sep. 11, 2009 and is a continuation in part ofapplication Ser. No. 12/358,411, filed Jan. 23, 2009 which claimspriority from provisional application Ser. No. 61/066,072, filed Feb.15, 2008. The entire contents of each of these applications areincorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a vascular device and more particularly to adevice for closing openings in vessel walls.

2. Background of Related Art

During certain types of vascular surgery, catheters are inserted throughan incision in the skin and underlying tissue to access the femoralartery in the patient's leg. The catheter is then inserted through theaccess opening made in the wall of the femoral artery and guided throughthe artery to the desired site to perform surgical procedures such asangioplasty or plaque removal. After the surgical procedure is completedand the catheter is removed from the patient, the access hole must beclosed. This is quite difficult not only because of the high blood flowfrom the artery, but also because there are many layers of tissue thatmust be penetrated to reach the femoral artery.

Several approaches to date have been used to close femoral access holes.In one approach, manual compression by hand over the puncture site isaugmented by a sandbag or weight until the blood coagulates. With thisapproach, it can take up to six hours for the vessel hole to close andfor the patient to be able to ambulate. This inefficiency increases thesurgical procedure time as well as the overall cost of the proceduresince the hospital staff must physically maintain pressure and thepatient's discharge is delayed because of the inability to ambulate.

In another approach to close the vessel puncture site, a clamp isattached to the operating table and the patient's leg. The clamp appliespressure to the vessel opening. The patient, however, must still bemonitored to ensure the blood is coagulating, requiring additional timeof the hospital staff and increasing the cost of the procedure.

To avoid the foregoing disadvantages of manual pressure approaches,suturing devices have been developed. One such suturing device, sold byAbbott, advances needles adjacent the vessel wall opening and pullssuture material outwardly through the wall adjacent the opening. Thesurgeon then ties a knot in the suture, closing the opening. Onedifficulty with the procedure involves the number of steps required bythe surgeon to deploy the needles, capture the suture, withdraw thesuture, and tie the knot and secure the suture. Moreover, the surgeoncannot easily visualize the suture because of the depth of the femoralartery (relative to the skin) and essentially ties the suture knotblindly or blindly slips a pre-tied knot into position. Additionally,the ability to tie the knot varies among surgeons; therefore success andaccuracy of the hole closure can be dependent on the skill of thesurgeon. Yet another disadvantage of this suturing instrument is thatthe vessel opening is widened for insertion of the instrument, thuscreating a bigger opening to close in the case of failure to deliver theclosure system. It is also difficult to pass the needle throughcalcified vessels.

U.S. Pat. No. 4,744,364 discloses another approach for sealing a vesselpuncture in the form of a device having an expandable closure memberwith a filament for pulling it against the vessel wall. The closuremember is held in place by a strip of tape placed on the skin to holdthe filament in place. However, the closure device is still subject tomovement which can cause leakage through the puncture. Additionally, ifthe suture becomes loose, the closure member is not retained and canflow downstream in the vessel. Moreover, since the suture extendsthrough the skin, a potential pathway for infection is created. Theclosure device in U.S. Pat. No. 5,545,178 includes a resorbable collagenfoam plug located within the puncture tract. However, since coagulationtypically takes up to twenty minutes and blood can leak in between theplug and tissue tract, manual pressure must be applied to the puncturefor a period of time, until the collagen plug expands within the tract.

It would therefore be advantageous to provide a device which would morequickly and effectively close openings (punctures) in vessel walls. Suchdevice would advantageously avoid the aforementioned time and expense ofapplying manual pressure to the opening, simplify the steps required toclose the opening, avoid widening of the opening, and more effectivelyretain the closure device in the vessel.

Commonly assigned U.S. Pat. No. 7,662,161 discloses effective vascularhole closure devices which have the foregoing advantages. It would befurther advantageous to provide a vascular hole closure device which isadjustable to accommodate different tissue thicknesses and applies amore constant clamping/retaining force between the intravascular andextravascular components of the device irrespective of tissue thickness.

SUMMARY

The present invention overcomes the disadvantages and deficiencies ofthe prior art. The present invention provides a device for closing anaperture in a vessel wall, the aperture having an external opening in anexternal region of the vessel wall and an internal opening in aninternal region of the vessel wall. The device comprises a coveringmember positionable inside the vessel against the internal opening ofthe aperture and having a dimension to prevent egress of fluid throughthe aperture and having a first opening. A first retainer ispositionable external of the vessel. A flexible connecting memberoperatively connects the covering member and the first retainer andadvances the retainer toward the covering member. The first opening ofthe covering member is configured to restrict movement of the connectingmember.

Preferably the connecting member comprises a first suture and the firstretainer is attached to the first suture whereby pulling of the firstsuture moves the first retainer toward the covering member.

The device may further comprise a second retainer movable toward thecovering member by pulling a second suture attached to the secondretainer. The covering member can have a second opening configured torestrict movement of the second suture. In preferred embodiments, thefirst and second retainers are spherical.

In preferred embodiments, the first and second retainers and the firstand second sutures are composed of a resorbable material.

In a preferred embodiment, the retainers are positioned in asubstantially side by side relationship in a placement position and arepositioned in a stacked relationship in a delivery position.

In one embodiment, the opening has a dimension to frictionally engagethe connecting member. In another embodiment, the opening includes aplurality of teeth to retain the connecting member.

The covering member is preferably pivotable between a longitudinalorientation for delivery and a transverse position for placement

The device may include a third opening for unrestricted movement of thefirst suture and fourth opening for unrestricted movement of the secondsuture.

In another aspect, the present disclosure provides a method of closingan aperture in a vessel wall, the aperture having an external opening inan external region of the vessel wall and an internal opening in aninternal region of the vessel wall. The method comprises the steps of:

-   -   inserting a covering member inside the vessel against the        internal opening of the aperture, the covering member having a        dimension to prevent egress of fluid through the aperture and        having a connecting member extending therefrom;    -   inserting a first retainer external of the vessel; and    -   applying a sufficient force to overcome resistance to movement        of the connecting member to advance the first retainer toward        the covering member.

In one embodiment, the step of advancing the first retainer comprisesthe step of moving a suture attached to the first retainer through anopening in the covering member having a diameter substantially the sameas the outer diameter of the suture. The method preferably includes thesteps of inserting a second retainer external of the vessel andadvancing the second retainer toward the covering member by pulling asecond suture connected to the second retainer.

In one embodiment, the step of advancing the first retainer comprisesthe step of moving a first suture attached to the first retainer throughan opening having a plurality of teeth engagable with the outer surfaceof the suture. In another embodiment, the step of advancing the firstretainer comprises the step of moving a first suture attached to thefirst retainer between bumps on the covering member.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a first embodiment of the closure deviceof the present invention;

FIG. 2 is a side perspective view of the covering (blocking) member ofthe closure device of FIG. 1 shown within a delivery sheath;

FIG. 3 is a side perspective view illustrating the covering member ofFIG. 2 deployed from the delivery sheath;

FIG. 4 is a side view illustrating one of the spherical retainers of theclosure device deployed from the sheath (the vessel wall shown incross-section);

FIG. 5 illustrates both spherical retainers deployed from the sheath;

FIG. 6 illustrates the sutures pulled to move the spherical retainerstoward the covering member for positioning in a side by siderelationship against the outer surface of the vessel wall;

FIG. 7 is a perspective view illustrating the retainers in the placementposition;

FIG. 8 is a perspective view of the covering member and sutures of analternate embodiment of the closure device of the present inventionshowing the sutures attached to the covering member via a looped suture;

FIG. 9 is a perspective view illustrating an alternate orientation ofthe retainers in the placement position;

FIG. 10 is a perspective view of another alternate embodiment of theclosure device of the present invention;

FIGS. 11-13C illustrate schematically the steps of insertion of theclosure device of FIG. 10 (the delivery sheath not shown for clarity)wherein:

FIG. 11 illustrates the covering member distal of the retainer tube andthe retainers inside the retainer tube;

FIG. 12 illustrates the retainers advanced from the retainer tube;

FIG. 13A illustrates the first retainer being advanced towards thecovering member;

FIG. 13B illustrates the first retainer further advanced toward thecovering member;

FIG. 13C illustrates the second retainer advanced toward the coveringmember;

FIG. 14 is a perspective of yet another alternate embodiment of theclosure device of the present invention;

FIG. 15 is a cross-sectional view taken along lines 15-15 of FIG. 14;

FIG. 16 is a bottom view of the covering member of FIG. 14;

FIG. 17 is a top view of a portion of the covering member of FIG. 14with the suture removed for clarity;

FIG. 18 is a cross-sectional view taken along lines 18-18 of FIG. 17;

FIG. 19 is a perspective view of yet another alternate embodiment of theclosure device of the present invention;

FIG. 20 is an exploded view of the spherical retainers and sutures ofFIG. 19;

FIG. 21 is a cross-sectional view taken along lines 21-21 of FIG. 19;

FIG. 22 is a cross-sectional view of a region of a covering member of analternate embodiment of the present invention;

FIG. 23 is a close up view of the area of detail designated in FIG. 22;

FIG. 24 is a perspective view of another alternate embodiment of theclosure device shown with the covering member plug separated from thecovering member;

FIG. 25 is a perspective view of the assembled closure member of FIG.24;

FIG. 26 is a top view of a region of the covering member of analternative embodiment;

FIG. 27 is a bottom view of a region of the covering member of anotheralternative embodiment;

FIG. 28 is a perspective view of an alternate embodiment of the closuredevice of the present invention;

FIG. 29 is a side view of the closure device of FIG. 28;

FIG. 30 is a bottom view of the closure device of FIG. 28;

FIG. 31 is a cross-sectional view of the covering member of the closuredevice of FIG. 28;

FIG. 32 is a cross-sectional view illustrating attachment of theretainer and suture;

FIG. 33 is a cross-sectional view illustrating an alternate attachmentof the retainer and suture;

FIG. 34 is a cross-sectional view illustrating another alternateattachment of the retainer and suture; and

FIG. 35 is a perspective view of another alternate embodiment of theclosure device of the present invention utilizing the retainer/sutureattachment of FIG. 34.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numeralsidentify similar or like components throughout the several views, FIG. 1is a perspective view of a first embodiment of the vascular hole(aperture) closure device of the present invention. The device isintended to close an aperture in the vessel wall, typically formed afterremoval of a catheter previously inserted through the vessel wall intothe vessel lumen for performing angioplasty or other interventionalprocedures. The aperture extends through the patient's skin andunderlying tissue, through the external wall of the vessel, through thewall of the vessel, and through the internal wall of the vessel tocommunicate with the internal lumen of the vessel. The closure device ofthe present invention has an intravascular component to block blood flowand an extravascular component to retain the intravascular component.

More specifically, the closure device includes a covering member orpatch positioned within the vessel against the internal wall of thevessel to block blood flow and two retainers positioned external of thevessel wall to retain the covering member in its blocking position. Eachretainer is preferably spherical in configuration and is fixedlyattached to a suture such that pulling of the suture advances theattached retainer toward the covering member to ultimately position theretainers in a side by side relationship either against or adjacent theexternal surface of the vessel wall.

Turning to FIGS. 1-7, a first embodiment of the closure device of thepresent invention is illustrated. Hole (aperture) closure device 10 hasa covering (blocking) member or patch 40 and first and second retainers20, 22. First and second retainers 20, 22 are preferably in the form ofa sphere or ball. The covering member 40 is dimensioned and configuredfor positioning inside the vessel on the internal side of the vesselaperture against the internal wall of the vessel; the retainers 20, 22are configured to be positioned outside the vessel wall adjacent orcontiguous the external side of the vessel aperture.

Covering member 40, preferably elongated in configuration as shown, isretained in a delivery sheath in a longitudinal position for delivery tothe vessel, and then pivots to a transverse position within the vessellumen (substantially perpendicular to an axis extending through theaperture) for orientation to cover (patch) the vessel aperture on theinternal side. This movement is illustrated in FIGS. 37A-37D of U.S.Pat. No. 7,662,161, the entire contents of which are incorporated hereinby reference (hereinafter the ‘161 patent). A comparison of FIGS. 2 and5 also shows pivoting of the covering member.

The spherical retainers are preferably held in the delivery tube in astacked relationship (see e.g. FIG. 11), with retainer 22 (222) atopretainer 20 (220) (or vice versa).

The elongated covering member 40 functions to cover (patch) the internalopening in the vessel wall to prevent the egress of blood. Withreference to FIGS. 1 and 4, the covering member 40 is preferablysomewhat oval shaped with elongated substantially parallel side walls 42a, 42 b and end walls 44 a, 44 b connecting the side walls 42 a, 42 b.Other shapes of the covering member are also contemplated. The end walls44 a, 44 b can have substantially straight wall portions, or curved wallportions. Covering member preferably has a thicker region 43 in thecentral region than the first and second end regions 45, 47. Otherdimensions are also contemplated.

The longitudinal axis of covering member 40 defines a lengthwisedimension and transverse axes define a shorter widthwise dimensions. Thewidthwise dimension of the covering member 40 is preferably, for a 6 Frdevice, in the range of about 2.5 mm to about 3.5 mm, and morepreferably about 3.3 mm. Other dimensions are also contemplated. Thewidth preferably is at least substantially equal to the dimension of theinternal opening in the vessel wall to effectively cover the opening. Ina preferred embodiment, the covering member 40 has a length in the rangeof about 7.5 mm to about 9 mm (in a 6 French system), and preferablyabout 8 mm.

It should be appreciated that alternatively the covering member could beprovided with an enlarged width region as illustrated in the embodimentof FIG. 1 of the '161 patent. The covering member could also beconfigured asymmetrically so that the enlarged region is off-centered toaccommodate widening of the aperture as the member is pulled at anangle. The covering member could also be configured in a paddle shapedwith a narrowed region adjacent a wider region as in FIGS. 9B-9E of the'161 patent. Other covering member configurations including thosedisclosed in the '161 patent could be utilized with the retainers ofthis present application.

The elongated covering member can be composed of materials such aspolycarbonate or polyurethane. Preferably it is composed of resorbablematerials such as lactide/glycolide copolymers that after a period oftime resorb in the body. If composed of resorbable material, thecovering member could optionally have regions of varying resorbability.Varying degrees of resorbability can be achieved for example byutilizing different materials having differing resorbablecharacteristics or by varying the mass of the covering member (increasedmass increases resorbtion time).

Spherical retainers 20 and 22 are preferably composed of resorbablematerial. In a preferred embodiment, the diameter of each retainer 20,22 is about 0.090 inches to about 0.095 inches, although otherdimensions are contemplated. Although shown as spheres, other roundedshapes are also contemplated. The retainers could alternatively be madeof non-absorbable polymeric or metallic material.

When the retainers 20 and 22 are released from the delivery instrument,they are spaced further from the covering member 40. They are thenconfigured to be advanced toward the covering member 40. Morespecifically, each retainer 20, 22 is fixedly secured to a respectiveflexible connecting member such as suture 30, 32. Sutures 30, 32 arepreferably made of polymeric material and are preferably resorbable,composed of a material such as polydioxanome. It is also contemplatedthat alternatively a metallic material could be utilized. The sutures,retainers and covering member can be made of the same or differentresorbable material, and/or have the same or different resorption times.

As shown, suture 30 has a free end 30 a and an opposite end 30 b securedto retainer 20 by molding, gluing, forming a knot, or other methods.Similarly, suture 32 has a free end 32 a and an opposite end 32 bsecured to retainer 22 in any of the foregoing manners. The suture isshown in the embodiment of FIG. 1 looped through the covering member.Other methods of attachment are also contemplated. For example, in thealternative embodiment of FIG. 8, sutures 150, 152 are attached tocovering member 140 by a loop of suture 160. Loop 160 extends upwardly(proximally) from the covering member 140 and the sutures 150, 152 arelooped through suture loop 160. Suture 160 can be attached to thecovering member 140 by various methods such as insert molding or bytying a knot in the suture under the covering member. In anotheralternate embodiment shown in FIG. 24, sutures 180, 182 are insertmolded to a plug 190. The covering member 192 has a recess 194 toreceive the plug 190. During manufacture, the plug 190 is wedged withinthe recess 194, creating a tight frictional fit. The plug 190 ispreferably flush with the distal surface 195 of covering member 192.Spherical retainers are designated by reference numerals 187, 188, arepreferably identical to retainers 20, 22, and illustrated in theadvanced position closer to proximal surface 197 of covering member 192.

To advance the retainers 20, 22 toward the vessel wall (and coveringmember), the free end of each suture is pulled proximally (in adirection of the arrow of FIG. 4, thereby moving the respective retainerin the opposite direction closer to the aperture A and vessel wall W.Once tightened against the tissue, a sufficient retention force ismaintained, i.e. a proximal pulling force on the covering member 40 topull it slightly proximally against the vessel wall. The retainers 20,22 therefore help to prevent the covering member 40 from separating fromthe vessel wall (e.g. moving in the direction toward the opposing vesselwall) which could create an unwanted gap between the covering member 40and the vessel opening to allow blood flow. The extent to which theretainers 20, 22 move toward the wall (and thus their distance from thevessel wall in their final placement position) will depend on the tissuethickness. Thus, the closure device can adjust for different tissuethicknesses and apply a constant retention force regardless of tissuethickness. The retainers of the other embodiments disclosed hereinfunction in a similar manner.

The delivery instrument for inserting the closure device extends throughan opening in the skin, through the tissue tract to the vessel, throughan external opening in the vessel wall, through the aperture in thevessel wall, and through an internal opening on the internal side of thevessel wall into the vessel lumen.

The covering member 40 in FIG. 2 is outside retainer tube 50 and, withindelivery sheath 60 in a tilted (pivoted) position. The covering member40 emerges from the sheath 60 and moves from a tilted position, morealigned or in preferred embodiments substantially aligned with thelongitudinal axis of the sheath, to a transverse position within thevessel (see FIG. 3). (Note the vessel wall is shown in FIG. 3 but therest of the vessel and tissue are removed for clarity.) The retainers20, 22 remain within tube 50. Note the covering member 40 can be ejectedby a pusher (not shown) contacting the side or top wall. Theretainers/covering members of the other embodiments disclosed herein canbe delivered in a similar manner as that of retainers 20, 22 andcovering member 40.

As shown in FIG. 4 covering member 40 is pulled proximally to abut theinternal opening on the internal side of the vessel W to cover (patch)the opening and the sutures extend through the opening A in the vesselwall. The first retainer 20 is shown ejected from the delivery sheath 60in FIG. 4 either by advancing the retainer, retracting the sheath aftera counterforce is applied by engagement of the covering member with thevessel wall, or relative movement of both. The second retainer 22 isstill within tube 50. The second retainer 22 is then deployed in asimilar manner as retainer 20 and is shown outside sheath 60 in FIG. 5.Note that in the delivery position, the retainers 20 and 22 arepreferably in a stacked relationship (such as in FIG. 11) to minimizethe transverse dimension of the delivery system.

Then, to retain the covering member 40 in position against the vesselwall to block blood flow therethrough, sutures 30 and 32 are pulledproximally from their free ends 30 a, 32 a in the direction of arrows Bof FIG. 6, thereby advancing the retainers 20, 22 distally in thedirection of arrows C toward the vessel wall V and covering member 40.As shown, the retainers 20, 22 can be moved to a position contiguous tothe vessel wall, or depending on tissue thickness, may be adjacent thewall with some tissue interposed between the retainers and vessel wall.The retainers 20, 22 in this position apply a proximal force on theelongated covering member 40 to limit movement of the covering memberinto the vessel. The retainers in this placement position are preferablyin a substantially side by side relationship as shown in FIG. 7.

As shown in FIG. 7, in the side by side relationship, the retainers 20and 22 are alongside in a transverse orientation with respect tocovering member 40. That is, they are positioned along the width of thecovering member 40. However it is also contemplated that the retainersin the placement position can be in a lengthwise orientation(substantially parallel to the longitudinal axis of the covering member)as shown in FIG. 9 where corresponding components to FIG. 7 (e.g.retainers 20′, 22′, sutures 30′, 32′, covering member 40′) have primedesignations. The retainers could also be in other side by sidearrangements at angles to the longitudinal axis. Alternatively, theretainers can be partially stacked in the placement position.

FIG. 10 illustrates an alternate embodiment of the closure device,designated by reference numeral 200. Closure device is substantiallyidentical to closure device of FIG. 1 except for the knot at the end ofthe suture to retain the suture. More specifically, suture 232 has afree end 232 a and a knotted end 232 b with a knot 236 to retainspherical retainer 222. Similarly, suture 240 has a free end 240 a and aknotted end 240 b with a knot 246 to retain spherical retainer 220. Thesutures are held in frictional engagement with a bore extending throughthe respective retainer 220,222. Covering member 290 is substantiallyidentical to covering member 40 of FIG. 1 with the sutures attachedthereto by a loop (not shown) as in FIG. 1. As the suture free ends 240a, 232 a are pulled, the respective spherical retainers 220, 222 areadvanced toward the covering member 240, as the knots 246, 236 abut theproximal end of the respective spherical retainers 220 and 222. Thus,the knots aid in the attachment of retainers 220, 222.

FIGS. 11-13C illustrate schematically a delivery system which can beutilized for placement of the closure devices described herein and showsschematically the device of FIG. 10 by way of example.

The delivery device includes a retainer tube 350 which is positionedwithin a delivery sheath (not shown). Retainer tube 350 has a distalopening 352 communicating with lumen 354 providing for passage of theretainers 220, 222 of closure device 200. Also positioned within thedelivery tube 350 is a pusher tube 360 which is preferably solid exceptfor two small lumens (not shown) dimensioned to receive a respectivesuture 240, 232.

In use, the retainer tube 350 with the retainers of the closure devicecontained within is placed in a delivery sheath (not shown). Whenpositioned within the delivery sheath, the retainers 220, 222 arecontained within the lumen 352 and the covering member 290 is positionedoutside the retainer tube 350, and held in a longitudinal position bythe walls of the delivery sheath. The covering member 290 is advancedfrom the delivery sheath into the vessel lumen by advancing the pushertube 360 against the second retainer 222 in the direction of the arrowof FIG. 11. Since in the delivery position the second retainer 222 abutsthe first retainer 220 which abuts the covering member 290, advancementof the pusher tube 360 advances the covering member 290 from thedelivery sheath.

Subsequently, the pusher tube 360 is moved further distally to advancethe retainers 220, 222 from the retainer tube 350 as shown in FIG. 12.Next, the first retainer 220 is advanced toward the covering member asshown in FIGS. 13A, 13B by pulling the suture 240 from its proximal endin the direction of the arrow. After placement of the first retainer220, the second suture 232 is pulled proximally in the direction of thearrow of FIG. 13C to advance the second retainer 222 toward the coveringmember 290. The sutures can then be severed leaving the retainers 220,222 and covering member 290 in place. It should be appreciated thatthese schematic views of FIGS. 11-13C omit the surrounding tissue andvessel portions for clarity. The covering member 290 is positionedinside the vessel lumen and the spherical retainers 220, 222 arepositioned outside the vessel lumen.

FIGS. 14-18 illustrate an alternate embodiment of the closure devicehaving a configuration to restrict movement of the connecting member,e.g. the suture, which connects the retainer to the covering member.

More specifically, the closure device 400 of FIG. 14 is similar to thedevice 200 of FIG. 10 except the covering member 490 has a first pair ofholes 494 a, 494 b and a second pair of holes 496 a, 496 b. The firstpair of holes 494 a, 494 b receive suture 440 and the second pair ofholes 496 a, 496 b receive suture 430. Holes 494 a, 496 a have a smallerdiameter than holes 494 b, 496 b. The larger hole 494 b is dimensionedto receive suture 440 for free unrestricted movement of the suture 440therethrough and therefore easier application of spherical retainer 420.Similarly, the larger hole 496 b is dimensioned to receive suture 430for free unrestricted movement of the suture 430 therethrough andtherefore for easier application (movement) of spherical retainer 422.Smaller hole 496 a is dimensioned to frictionally engage suture 430 sothat tension is applied to the suture 430. It is dimensioned so that thesuture 430 can be pulled through the hole 496 a if sufficient force isapplied by pulling on free end 430 a, but if such predetermined force isnot applied, the suture will remain frictionally engaged within the wallof the opening 496 a and not move. In this manner, when the user ceasespulling on free end 430 a, the suture 430 and thus the sphericalretaining ball 422 will remain in position. Suture 440 operates in asimilar manner, with smaller opening 494 a dimensioned to frictionallyengage and resist movement of the suture 440 to retain sphericalretainer 420. FIGS. 15-18 show how the suture is looped through therespective opening.

In an alternate embodiment, a plurality of internal teeth can beprovided to enhance the retention of the suture within the smallerdiameter hole. This is shown for example in FIGS. 22 and 23 wherein hole496 a′ has a plurality of teeth 497 formed on the interior wall of thesmaller opening. Engagement of the suture 430′ by the teeth 497 retainsthe suture 430 and spherical retainer. Note that the teeth 497 can beformed to angle inwardly so the suture 430 can be moved in only onedirection, i.e. proximally so the retainer is advanced toward thecovering member. Similar teeth can be provided in the other small holefor retaining the other suture and retainer.

In the embodiment of FIG. 26, the opening 522 in covering member 520 hasa triangular wedge shape region 523. The region 523 has a reduced sizeopening, narrowing to a diameter less than an outer diameter of thesuture 530 extending therethrough. The clinician can move the suture 530into the narrow (reduced diameter) region 523 when desired to apply agripping force on the suture 530 to retain the suture in place. Opening524 is dimensioned larger than the outer diameter of the suture 530 toallow free unrestricted movement therethrough. Only one of the pair ofopenings is shown in the portion of the covering member 520 illustratedin FIG. 26, it being understood that a second similar pair of openingsfor the second suture can be provided. In all other respects the closuredevice can be identical to closure device 200 of FIG. 10 or otherdevices disclosed herein.

In the embodiment of FIG. 27, the retention of the suture is enhanced byinwardly directed bumps 560 a, 560 b, 560 c and 560 d on the undersideof the covering member 570. That is, the suture (not shown) extendingthrough large and small openings 570, 572, respectively, is gripped bythe bumps 560 a, 560 b as the distance between opposing bumps isslightly less than the diameter of the suture. Sufficient tension (e.g.pulling force by the clinician), overrides the frictional force of thebumps 560 on the suture. Similarly a suture (not shown) extendingthrough large and small openings 574, 576 is frictionally restrained bybumps 560 c, 560 d. The sutures connect retainers to the covering member550 and are configured to be pulled to advance the retainers to thecovering member in the manner described above with respect to the otherembodiments. The bumps 560 can be utilized as a supplement to the smallopening frictional engagement as is the embodiment of FIG. 14 oralternatively as the sole retention feature with two pairs of largeropenings in the covering member.

FIGS. 19-21 illustrate an alternate embodiment of the closure device,designated generally by reference numeral 600, having a suture 610extending transversely and joining spherical retainers 620 and 622. Aknot 610 a, 610 b is formed on each end of the suture 610 to retain theretainers 620, 622. Connecting suture 630 has a looped proximal end 632through which suture 610 extends. This loop 632 is tightened to securesuture 610. Both ends 631, 632 of the looped suture 630 extend thoughfirst opening 641 in covering member 640. End 632 terminates in knot 633to connect suture 630 to covering member 640 (due to its diameter largerthan opening 641). The other end 637 loops through covering member 640,exiting through opening 642 in suture portion 635. Openings 642, 641 canbe large and small openings functioning similar to the large and smallopenings of the embodiment of FIG. 14. That is, the openings can beconfigured to provide for free movement and tighter frictionalengagement as in the embodiment of FIG. 14.

Pulling of suture end 630 a advances the retainers 620, 622 togethertoward the covering member 640 due to the engagement of suture 630 withthe transverse suture 610.

FIGS. 28-31 illustrate an alternate embodiment of the closure device,designated generally by reference numeral 700. Device 700 is similar todevice 400 except for the way the suture and retainer are attached andthe suture openings in the covering member. More specifically, closuredevice 700 has a first suture 730 and a second suture 740. Retainer 722,preferably spherical in configuration, is connected to suture 730 andretainer 720, preferably spherical, is connected to suture 740.

Covering member 790 has a first pair of holes 794 a, 794 b and a secondpair of holes 796 a, 796 b. The first pair of holes 794 a, 794 b receivesuture 740 and the second pair of holes 796 a, 796 b receive suture 730.Holes 794 a, 796 a have a smaller diameter than holes 794 b, 796 b. Thelarger hole 794 b is dimensioned to receive suture 740 for freeunrestricted movement of the suture 740 therethrough and thereforeeasier application of spherical retainer 720. Similarly, the larger hole796 b is dimensioned to receive suture 730 for free unrestrictedmovement of the suture 730 therethrough and therefore for easierapplication (movement) of spherical retainer 722.

Smaller hole 796 a is dimensioned to frictionally engage suture 730 sothat tension is applied to the suture 730. It is dimensioned so that thesuture 730 can be pulled through the hole 796 a if sufficient force isapplied by pulling on free end 730 a, but if such predetermined force isnot applied, the suture will remain frictionally engaged within the wallof the opening 796 a and not move. As shown in the cross-sectional viewof FIG. 31, the hole 796 a has an inwardly angled wall 797 transitioninginto a reduced diameter region 798 and an outwardly angled wall 799transitioning back to a larger diameter. The angled walls 797, 799facilitate movement of the suture 730 when tension is applied, with thereduced diameter region 798 frictionally securing the suture. Hole 794 ahas a similar configuration as hole 796 a and thus contains similarangled walls. In this manner, when the user ceases pulling on free end730 a, the suture 730 and thus the spherical retaining ball 722 willremain in position. Suture 740 operates in a similar manner, withsmaller opening 794 a dimensioned to frictionally engage and resistmovement of the suture 740 to retain spherical retainer 720.

FIG. 32 illustrates one method of attachment of the suture to aspherical retainer. Spherical retainer 720 has a through hole 721extending therethrough. Hole 721 has a first portion 721 a having afirst diameter and a second portion 721 b having a second largerdiameter. A crimp or a bead 743 is attached to the suture 740, creatinga diameter larger than the diameter of portion 721 a. Thus, the wall ofthe through hole 721 forms a shoulder 723 to block movement of thespherical retainer 720. Preferably, the end 741 of the suture issubstantially flush with the spherical retainer 720. The crimp or beadis of substantial transverse dimension to frictionally engage the secondportion 721 b. Consequently, this frictional engagement prevents theretainer 720 from sliding in the direction away from the covering member790 while the shoulder 723 prevents the retainer 720 from sliding in thedirection toward the covering member 790. The retainer 722 and suture730 preferably have the same structure and engagement/retention asretainer 722 and suture 740.

In the alternate embodiment of FIG. 33, the suture 740′ has a knot 747formed at its end. The shoulder 723′ provides a stop for movement ofretainer 720′ away from covering member 790′, as the diameter of portion721 a′ of opening 721 is less than the transverse dimension of the knot747. The knot 747 is of sufficient transverse dimension to frictionallyengage the second portion 721 b′ to prevent the retainer 720′ fromsliding in the direction away from the covering member 790.

In the embodiment of FIGS. 34 and 35, a suture 834 forming a loop 835has a knot 837 at one end. This suture knot 837 frictionally engagesportion 821 b of the hole 821 formed in the retainer 820. A reduceddiameter hole portion 821 a forms a shoulder 823 to block movement ofthe knot 837. As shown, the looped end 835 of suture 834 receives suture830. Consequently, tension applied to the ends 830 a of suture 830 pullthe loop 835 upwardly (as viewed in the orientation of the FIG. 35) awayfrom the covering member 890 to advance spherical retainer member 822toward the covering member 890. A second suture 854 identical to suture834 has a loop to receive suture 840 in the same manner as suture 830.Suture 854 and 840 are identical to sutures 834 and 830, respectively,except that they function to secure and move spherical retainer member820. Consequently, when the ends 840 a of suture 840 are pulledproximally, the suture 854, attached within an opening in the retainer820 in the identical manner as suture 834, pulls the retainer 820 towardthe covering member 890.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

1. A device for closing an aperture in a vessel wall, the aperturehaving an external opening in an external region of the vessel wall andan internal opening in an internal region of the vessel wall, the devicecomprising: a distal covering member positionable inside the vesselagainst the internal opening of the aperture, the covering member havinga dimension to prevent egress of fluid through the aperture, thecovering member having a first opening and a second opening; a proximalfirst retainer positionable external of the vessel and engageable withtissue to retain the distal covering member; and a flexible connectingmember operatively connecting the covering member and the first retainerfor placement of the closure device to close the aperture in the vesselwall, the first retainer fixedly secured to the connecting member, theconnecting member advancing the first retainer toward the coveringmember, the first opening of the covering member configured tofrictionally engage the flexible connecting member to restrict movementof the connecting member until a predetermined force is applied and thesecond opening having a larger diameter than the first opening forunrestricted movement of the flexible connecting member, whereinmovement of the flexible connecting member in a proximal direction awayfrom the covering member advances the first retainer toward the coveringmember in a distal direction.
 2. The device of claim 1, wherein theconnecting member comprises a first suture.
 3. (canceled)
 4. The deviceof claim 2, wherein the first retainer is spherical in configuration. 5.The device of claim 1, further comprising a second retainer movabletoward the covering member.
 6. The device of claim 5, further comprisinga second flexible connecting member, the second retainer attached to thesecond connecting member and pulling of the second connecting memberadvances the second retainer toward the covering member, the coveringmember having a third opening configured to restrict movement of thesecond connecting member.
 7. The device of claim 6, wherein the secondretainer is spherical in configuration.
 8. The device of claim 1,wherein the covering member is composed of a polymeric material.
 9. Thedevice of claim 1, wherein the covering member and first retainer arecomposed of a resorbable material.
 10. The device of claim 2, furthercomprising a second suture and a second retainer attached to the secondsuture, the second suture advancing the second retainer toward thecovering member.
 11. The device of claim 10, wherein the first andsecond retainers are positioned in a substantially side by siderelationship in a placement position and are positioned in a stackedrelationship in a delivery position.
 12. The device of claim 10, whereinthe first and second retainers are in a transverse orientation withrespect to the covering member in a placement position.
 13. The deviceof claim 10, wherein the first and second retainers and the first andsecond sutures are composed of a resorbable material.
 14. (canceled) 15.The device of claim 1, wherein the covering member is pivotable betweena more longitudinal orientation for delivery and a transverse positionfor placement.
 16. The device of claim 6, further comprising a a fourtha fourth opening in the covering member for unrestricted movement of thesecond suture. 17-20. (canceled)
 21. The device of claim 1, wherein theflexible connecting member has a first portion, a second free endportion, and an intermediate portion positioned between the firstportion and the second portion, the first retainer is secured to thefirst portion and the intermediate portion loops through the coveringmember.
 22. The device of claim 1, wherein the flexible connectingmember loops through the first and second openings.
 23. The device ofclaim 10, wherein the covering member has a third opening having a firstdiameter smaller than a second diameter of the fourth opening tofrictionally engage the second suture to restrict movement of the secondsuture.